Regulation (EC) No 1332/2008 on food enzymes - the so called 'Framework regulation' - harmonised the rules on food enzymes for the first time in the EU and fixed a deadline of 2 years for the submission of applications for authorisation.
Meanwhile, the Commission reached the conclusion that the initial deadline for submitting applications was insufficient in order to allow stakeholders and in particular small and medium size enterprises to produce all necessary data within that period. Therefore, the 24-month period was extended to 42 months by Commission Regulation (EU) No 1056/2012 amending Regulation (EC) No 1332/2008.
Industry has had now 3,5 years to make available the information for the risk assessment of food enzymes and submit applications on existing and new enzymes starting from 11 September 2011 (Regulation (EC) No 234/2011). These food enzymes are in the process of being evaluated for safety by EFSA and will be approved by 'comitology' procedure (establishing the EU list).
Until the EU list of food enzymes is drawn up, national rules on the marketing and use of food enzymes and food produced with food enzymes will continue to apply in EU countries.
Other pieces of EU legislation relevant to food enzymes are the following:
- Regulation (EC) No 178/2002 lays down the general principles and requirements of food law.
- Regulation (EC) No 1331/2008 - establishes the common authorisation procedure for food additives, food enzymes and food flavourings.
Both Regulation (EC) No 178/2002 and Regulation (EC) No 1331/2008 were amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain amended with effect from 27 March 2021. Further information on the implementation of that Regulation can be found on DG SANTE’s website.
- Regulation (EU) No 234/2011 implements the common authorisation procedure and applies from 11 September 2011. That Regulation has been amended by Commission Implementing Regulation (EU) No 562/2012 which lays down derogation from submitting toxicological data in some specific cases and the possibility of grouping food enzymes under one application under certain conditions. It has also been adjusted by Commission Implementing Regulation (EU) 2020/1823 to accommodate the changes linked to Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain. These new provisions are applicable to applications submitted from 27 March 2021.
Food enzymes labelling rules
Regulation (EU) No 1169/2011 on the provision of food information to consumers
Enzyme Regulation - Articles 10 to 13: Specific labelling requirements for food enzymes and food enzyme preparations
What enzymes does the Regulation cover?
Only food enzymes added to food for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of food, including enzymes used as processing aids.
What enzymes does the Regulation not cover?
Enzymes intended for human consumption e.g. for nutritional or digestive purposes;
Food enzymes used in the production of food additives under Regulation EC 1333/2008 and in the production of processing aids.
Microbial cultures traditionally used in the production of food (cheese, wine), which may incidentally produce enzymes but are not specifically used to produce them, are not considered food enzymes.
This guidance document has been produced by the Commission services after consultation with the EU countries’ experts on food enzymes and the relevant stakeholders with the aim of providing informal guidance for Food Business Operators and competent authorities on criteria for determining the status of a food enzyme either as an ingredient or as a processing aid in a given context of use, and hence whether it needs to be listed in the ingredient list of foods intended for the final consumer. Such criteria will help applicants prepare an appropriate application for authorisation of food enzymes. The guidance also includes a decision tree to facilitate this categorisation.
This Guidance document was endorsed by a majority of the representatives of the EU countries at the meeting of the Standing Committee on the Food Chain and Animal Health on 20 February 2014.